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目的:考察苦黄缓释微丸的制备及其质量指标。方法:利用流化床包衣设备,采用薄膜包衣法制备苦黄缓释微丸,以总蒽醌为指标性成分,测定缓释微丸的释放度,并考察了包衣处方工艺因素对药物释放的影响。结果:流化床薄膜包衣法成功制备了苦黄缓释微丸,其Eudragit RS 30D与Eudragit RL 30D的用量比例为1∶0时,包衣增重为14%;累积释放百分率2h26%,6h70%,12h90%。结论:水性薄膜包衣技术制备苦黄缓释微丸,具有良好的体外缓释行为。
Objective: To investigate the preparation of Kuhuang sustained-release pellets and its quality indicators. Methods: By using fluidized-bed coating equipment, Kuhuang sustained-release pellets were prepared by film coating method. Total anthraquinone was used as index component to determine the release of sustained-release pellets. The effects of coating process factors Effect of drug release. Results: The Kuhuang sustained-release pellets were successfully prepared by the fluidized-bed coating method. The coating weight gain was 14% when the ratio of Eudragit RS 30D to Eudragit RL 30D was 1: 0. The cumulative release percentage was 2h26% 6h70%, 12h90%. Conclusion: Water-based film coating technology for the preparation of Kuhuang sustained-release pellets, with good in vitro release behavior.